Last Updated on: 28th July 2023, 07:22 pm

Pharmacists serve an important role in the healthcare system. But they also operate in a highly regulated environment. Pharmacies and pharmacists must strictly follow rules governing the dispensing of controlled substances and other drugs. State boards of pharmacy and the federal Drug Enforcement Administration (DEA) oversee compliance.

If the DEA or state pharmacy board targets you for an audit or investigation, your livelihood may be on the line. These in-depth reviews examine your records, dispensing practices, inventories, security protocols, and more. The stakes are high if violations are found, with discipline ranging from fines to license suspension or revocation.

With the right preparation, you can effectively respond to a board of pharmacy or DEA investigation. Here is what pharmacists need to know to come through scrutiny with their reputation and career intact.

Common Red Flags That Prompt Investigations

Before we get into preparation strategies, it’s useful to understand what puts pharmacists on investigators’ radar in the first place. Some of the most common red flags include:

• Unusually high dispensing volumes – The DEA and state boards keep close tabs on prescribing and dispensing statistics. Abnormally high volumes of controlled substances compared to peer pharmacies raise suspicions of illegal diversion or reckless dispensing practices.
• Prescriptions from problematic prescribers – Pharmacies that fill large numbers of prescriptions from doctors already facing scrutiny or with histories of negligence or overprescribing tend to attract attention.
• Multiple prescriptions to patients – Similarly, filling many controlled substance prescriptions from a single provider to individual patients (especially combinations of opioids, sedatives, and stimulants) raises diversion concerns.
• Cash payments – A high percentage of cash transactions for controlled substance prescriptions versus insurance is another red flag, as it circumvents reporting requirements and pharmacy controls.
• Inventory issues – Faulty or inconsistent recordkeeping, losses or theft not properly accounted for, out-of-balance inventories, and sloppy handling of CII drugs during ordering, receipt, or stocking can prompt audits.
• Prescription monitoring program issues – Inconsistencies between a pharmacy’s dispensing data and state prescription drug monitoring program (PMP) records are an obvious oversight concern.
• Patient complaints – When patients complain to the authorities about questionable dispensing practices, it guarantees scrutiny from oversight agencies.

With risks like that, it pays to be cautious in your dispensing practices. But you should also know your rights and be ready to respond if an audit or complaint does trigger an investigation.

Handling the Investigation Process

If you get word of a pending DEA or board of pharmacy investigation, you’ll need to take proactive steps:

Secure experienced legal counsel – Your first priority should be retaining an attorney experienced in representing pharmacists and pharmacies before the DEA and state regulatory boards. They’ll advocate for your interests every step of the way.

Cooperate fully – Be responsive to all requests for records, interviews, pharmacy visits, inventories, surveillance footage, or other information. Lack of cooperation is grounds for charges. Answer investigators’ questions directly but provide minimal extraneous information.

Conduct an internal audit – Re-examine your records, inventories, dispensing data, documentation practices, recordkeeping, security protocols, and personnel matters. Know precisely what investigators will find. Refine policies and practices where needed.

Consider negotiation – In some cases, it may be advantageous to try negotiating a settlement to avoid draconian sanctions. This is where experienced pharmacy regulatory counsel can guide you.

Prepare your defense – If negotiations fail, prepare to defend yourself at an administrative hearing. Your lawyer will demonstrate compliance, argue that charges are unfounded, and present mitigating circumstances. You may also leverage stellar records of dispensing safely and preventing diversion.

Obtain supporting experts – Qualified pharmacy practices experts can be engaged to independently review your records and operations and testify to their appropriateness. Their objective opinions often sway decisions.

Appeal adverse actions – If the ruling goes against you, all is not lost. Decisions can frequently be appealed or modified. Dedicated counsel will fight to overturn or reduce penalties. With preparation and perseverance, you can achieve the best possible outcome when facing a DEA or board investigation.

Selecting the Right Pharmacy Lawyer

Navigating DEA and board of pharmacy investigations is challenging. Having the right lawyer can level the playing field. Be sure to look for these traits:

• Deep experience – Look for plentiful experience defending pharmacists before the DEA and state pharmacy boards specifically. The nuances and strategies involved are specialized.
• Pharmacy insights – Opt for legal counsel with in-depth understanding of pharmacy workflows, regulatory frameworks, records, and terminology. This fosters effective communication and representation.
• Administrative hearing skills – Not all investigations end in settlement. Be sure your lawyer has experience bringing pharmacy cases through administrative hearings and appeals processes when needed.
• Negotiation ability – Savvy and diplomatic negotiation can resolve many cases advantageously. Look for counsel adept at securing fair settlements with regulators. This minimizes risk.
• Good investigator relationships – Respected lawyers develop working relationships with investigators. This enables cooperation, information gathering, and potential settlement opportunities.
• Resources to match the regulators – State and federal agencies bring significant resources to bear in these cases. Choose counsel with comparable bandwidth to mount a robust response.
• Meticulousness – These cases come down to minute details. Meticulous, organized attorneys will excel at navigating the complexity.
• Communicativeness – Look for lawyers who frequently update clients and take time to explain issues in practical terms pharmacists understand. You need insight to make sound decisions.
• Passion for pharmacy law – Representing pharmacists should be a true calling for your counsel, not just another regulatory case. Select lawyers who champion pharmacy rights.

The pharmacy law group at Spodek Law meets each criteria. Their veteran attorneys offer deep pharmacy regulatory defense experience. Leveraging pharmacy expertise, negotiation skills, and diligent advocacy, they routinely secure positive outcomes for pharmacists facing DEA and board investigations nationally.

Don’t leave your career and reputation to chance. If you’re facing a DEA or state board of pharmacy investigation, consult a respected pharmacy law firm like Spodek. Their battle-tested lawyers will protect your interests, license, and livelihood at every turn.